Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

Launched by WOMEN AND INFANTS HOSPITAL OF RHODE ISLAND · May 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Jada® System to see if it is better at controlling heavy bleeding after childbirth, known as postpartum hemorrhage (PPH), compared to the usual treatments. The trial will involve 424 women who have experienced significant blood loss after delivery. Researchers want to determine if the Jada® System is effective, safe, and cost-effective in treating this serious condition that can lead to maternal death.

To be eligible for this trial, women must be at least 18 years old, have delivered their baby at least 34 weeks into the pregnancy, and have lost more than 1000 milliliters of blood within the first 24 hours after giving birth. Participants will receive either the Jada® System or standard care and will be monitored throughout the process. This research could provide important information that helps improve care for women experiencing postpartum hemorrhage. If you meet the criteria and are interested, please talk to your healthcare provider for more information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Delivery at 34 weeks or greater
• • Cumulative blood loss \>1000ml within 24 hours after delivery
• • Uterine atony
• • Receipt of first-line uterotonics
• • Cervix at least 3cm dilated at cesarean section
• Exclusion Criteria:
• • Patient unwilling or unable to provide informed consent
• • Retained placenta or other known cause of postpartum hemorrhage
• • Placenta accreta spectrum
• • Coagulopathy
• • Rupture uterus
• • Surgical management immediately needed for life-threatening bleeding
• • Known contraindication for Jada System; ongoing intrauterin pregnancy, untreated uterine rupture, unresolved uterine inversion, current cervical cancer, unknown uterine anomoly, current purulent infection